Challenges of Clinical Studies at Sites Unfamiliar with Research Regulations: Factors to be Considered

Emmanuel Nwabueze Aguwa

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Chapter 5 Challenges of Clinical Studies at Sites Unfamiliar with Research Regulations: Factors to be Considered

In: An African Research Ethics Reader

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Emmanuel Nwabueze Aguwa

Emmanuel Nwabueze Aguwa
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Type:: Chapter

Pages:: 72–91

DOI:: https://doi.org/10.1163/9789004697676_006

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Abstract

This chapter explains that clinical trials are research studies in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control groups) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. This process constitutes the primary way researchers discover if new treatments, like a new drug (e.g., a vaccine) or a medical device (e.g., a heart valve) is safe and effective in people. With the onset of emerging and re-emerging diseases and other health conditions, clinical trials have become indispensable for advancing knowledge and cure for diseases. Also, while some developing countries are often skeptical about the conduct of clinical trials in their areas due to lack of trust, they are also worried about implementing the findings of trials conducted in either developed countries or in developing countries outside their own. This was brought to light at the peak of the Covid-19 vaccine trial period. The cultural and scientific mix of this complicated process, especially at study sites that are not used to it, are the core of its analysis.

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An African Research Ethics Reader

From the Ground Up

Series: Africana Philosophy, Volume: 1

E-Book ISBN:: 9789004697676

Publisher:: Brill

Print Publication Date:: 18 May 2024

Subjects
- African Studies
  - Sociology & Anthropology
- Philosophy
  - Bioethics / Ethics of Medicine

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Chapter 5 Challenges of Clinical Studies at Sites Unfamiliar with Research Regulations: Factors to be Considered

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An African Research Ethics Reader

From the Ground Up

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